bioworld - Medical Device Daily

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weight loss. Together, they amounted
to about 300,000 procedures in 2008.
There are close to 20 million obese candidates
for bariatric surgery in the U.S.
Restrictive operations that make the
stomach smaller, such as adjustable
gastric banding (gastroplasty procedure),
create a full feeling after a small
meal. Larry Biegelsen, a med-tech analyst
for Wachovia Capital Markets, in a
research note said that Wachovia
expects the global banding market to
reach $1 billion in 2011, up from $320
million in 2007.
Factors that should help the U.S. market
growth stay robust, according to
Biegelsen’s research note, include the
“vastly underpenetrated” U.S. population
of bariatric surgery candidates.
Only 1 percent of the 20 million
Americans who would qualify for
bariatric surgery have it done.
The note said that increased penetration
into the obese population sector
should be driven by increased awareness
of surgical options for patients
through Allergan Inc.’s and Johnson &
Johnson’s increased marketing efforts;
increased insurance coverage; the
potential for expanded indications;
and recent positive outcomes data.
But a changing trend in bariatric surgery
in Europe could spell trouble for
the U.S. gastric banding market,
Biegelsen noted. “Our contacts indicate
that gastric banding is falling out
of favor in key markets, including
Germany and Switzerland, due to
long-term complications,” Biegelsen
said. “The Lap-Band has been available
in [Europe] about 10 years longer
than in the U.S., and we understand
that complications that emerge at four
to five years post-op have discouraged
some [European] surgeons from continued
use. Surgeons are moving to
more invasive procedures including
gastric bypass, gastric sleeving, and
duodenal switch. “This is the largest
risk to our U.S. banding forecasts,
THE BIOWORLD AND MEDICAL DEVICE DAILY OBESITY REPORT
given that U.S. surgeons are approaching
five-year follow-up over the next
few years.”
Biegelsen said that gastric sleeving
might emerge as a threat to the banding
market in when it receives insurance
coverage. While gastric sleeving
is more invasive than banding and targeted
for the extremely obese, U.S.
and European doctors are optimistic
about it because of its improved
weight loss profile of 40 percent to 60
percent at one to two years, Biegelsen
said. Gastric sleeving also has lower
comparable side effects to banding,
he noted.
Allergan – Lap-Band
Allergan Inc., of Irvine, Calif., markets
the Lap-Band Adjustable Gastric
Banding System for obesity. Its name
comes from the minimally invasive surgical
technique used – laparoscopy –
and the silicone gastric band. The
band uses a silicone ring filled with
saline placed around the top of the
upper part of a patient’s stomach,
which then creates a smaller stomach
pouch. It helps patients control their
weight and lose weight by reducing
the amount of food that the stomach
can hold at one time and by making
patients feel fuller sooner. Allergan’s
Omniform technology allows the Lap-
Band System to maintain controlled,
even and round inflation throughout the
adjustment range of the band. It was the
first adjustable medical device for individualized
weight loss and the first minimally
invasive surgical approach
approved in the U.S. by the FDA.
According to the product website,
patients using the Lap-Band System
may see weight loss of two to three
pounds a week in the first year, but
about one pound per week is more
likely. As time goes by, the amount of
weight lost is usually less. Many
patients lose weight more quickly with
gastric bypass surgery, but at three
years, Lap-Band users often show a
comparable amount of weight loss.
According to the Lap-Band website,
the costs of the procedure (including
the facility, surgeon and anesthesiologist)
range from $12,000 to $25,000.
After the first year, there may be additional
costs for follow-up visits that
range from $35 to $200 each. Many
health plans now cover Lap-Band surgery,
including Medicare, and
Medicaid in some states. Insurance
companies that either partially or fully
cover Lap-Band surgery include Aetna,
Blue Cross in some states, Humana
and United Healthcare, among others.
The Lap-Band System was introduced
outside of the U.S. in July 1994 (to be
used by surgeons trained at Allerganapproved
centers). U.S. clinical trials
started in June 1995, and the FDA
approved the Lap-Band for general
use in June 2001. More than 500,000
Lap-Band System devices have been
distributed worldwide, and it is the
No. 1 selling adjustable gastric band
for weight loss worldwide, according
to the company.
The Lap-Band is for use by people 18
years and older who are at least 100
pounds overweight (or twice their
ideal weight), or who have a BMI of 40
or higher (or 35 or higher, if co-morbidities
such as Type II diabetes exist).
Allergan also has introduced the Lap-
Band AP System to extend the performance
of the original Lap-Band
System. The next-generation system,
introduced in the U.S. in 2007, uses
patented Omniform technology, which
is designed to minimize the potential
for leaks due to unwanted creases or
folds (called crease-fold failure).
According to Allergan, Omniform introduces
a 360 degree inflation area that
“evenly distributes pressure for complete
coverage of stomach anatomy.”
The product website lists a number of
advantages of Lap-Band. It is a minimally
invasive surgical approach that
requires no intestinal re-routing, cutting
or stapling of the stomach wall or